Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for Glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence
A study with the suitable source substance Glycerides, C16 - 18 and C18 -unsaturated mono- and di-, citrates (CAS 91052-16-3) indicates ready biodegradability in a GLP study performed according to OECD 301 F (81% after 28 d; O2 consumption; read-across). Thus, the target substance does not meet the screening criterion for persistency and it is not considered to be persistent (P) or very persistent (vP).
Bioaccumulation
Glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7)i s characterised by low water solubility (129 µg/L), and a high log Kow (5.57 - >10; EPISuite v4.11) for representative constituents. Based on the physico/chemical properties such as poor water solubility and high potential for adsorption a reduced availability in water is expected. In addition, available literature data indicated the non-toxic properties of fatty acids since they can be used as energy source. It can be concluded that the bioaccumulation potential of Glycerides, C16 -18, mono- and di-, citrates is negligible. Thus, the substance is not considered to be B or vB.
Toxicity
All acute effect concentrations available for Glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7) are > 0.1 mg/L (fish, aquatic invertebrates, algae, aquatic plants) and the available chronic effect concentration (algae, aquatic plants) is ≥ 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. Therefore, the test substance is not considered to meet the T criterion.
In conclusion, the substance is not PBT/vPvB.
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